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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Toledo, Charles M.D. Close out Letter 4/6/10


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  Center for Biologics Evaluation
and Research
1401 Rockville Pike
Rockville, MD 20852-1448

April 6, 2010

Charles Toledo, M.D.
Western North Carolina Pediatric and Adolescent Care
293 Hospital Road, Suite D
Sylva, North Carolina 28779

Dear Dr. Toledo:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter CBER-10-05 dated March 11, 2010. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Gilliam B. Conley, Director
Division of Inspections and Surveillance
Office of Compliance and Biologics Quality

cc: John Gridley, District Director
60 Eighth Street NE
Atlanta, Georgia 30309